To: Members of the Senate Health, Education, Labor, and Pensions Committee
From: The Consumer Advocates for Smoke-free Alternatives Association
Re: May 15, 2014 Hearing on E-Cigarettes
Date: May 14, 2014
The Consumer Advocates for Smoke-free Alternatives Association (CASAA) has serious concerns about the hearing involving e-cigarettes scheduled for Thursday, May 15th. Specifically, we believe that inviting Dr. McAfee and Mr. Zeller as the sole witnesses will not offer well-rounded or even completely accurate information.
CASAA asks for your help in ensuring that the Senate hearing is not simply a platform for CDC and FDA to present misinformation, unchallenged.
Both CDC and FDA have demonstrated they are intent on reducing the availability, quality, and use of e-cigarettes. They are apparently unconcerned that e-cigarettes have proven to be an effective method for hundreds of thousands of American smokers to quit smoking, substituting an alternative that is estimated to be 99% less harmful than smoking. Often this substitution worked for them after every other method of quitting smoking failed. Indeed, these agencies are willing to mislead the American public into believing that e-cigarettes are highly hazardous and are not helping people quit. They have repeatedly presented misleading interpretations of data and are paying to have misleading data created. There have been hundreds of analyses written that show how these agencies have systematically misled the American people, and we expect they will attempt to do the same to Congress.
CDC Director Frieden has aggressively dismissed the evidence that people have quit smoking using e-cigarettes as “anecdotes.” These “anecdotes” he dismisses include tens of thousands of heart-wrenching stories of people who tried to quit smoking, often using every method recommended by CDC, and failed until they discovered e-cigarettes. CASAA has collected and published over 6,000 such individual stories, and other ad hoc collections include a thousands more. Moreover, the reason that we do not have systematic population data about what portion of American smokers have quit using e-cigarettes is because CDC and other units of the Department of Health and Human Services, which normally collect such data, have avoided doing so. Systematic studies in France and the United Kingdom, where e-cigarettes are only slightly more popular than they are here, have estimated that as much as 1% of the population (1% of the whole population, not 1% of smokers) have quit smoking by using e-cigarettes. This would make the free market in e-cigarettes more important for smoking cessation than anything CDC, FDA, or any other government agency has done for decades.
Despite denigrating the thousands of honest and informative success stories as “mere anecdotes,” CDC is now paying to find genuinely uninformative anecdotes: a handful of people who, despite cutting back or eliminating smoking via a low-risk alternative, nonetheless developed a serious illness that is sometimes caused by smoking. CDC is ostensibly looking for "real people to appear in ads about the health effects of smoking cigarettes" who are ex-smokers who:
- For at least a year, used e-cigarettes or smokeless tobacco while continuing to smoke some cigarettes; and
- Thought using e-cigarettes or smokeless tobacco to cut back on some cigarettes would be good for your health; and
- Despite cutting back, you were later diagnosed with a serious health condition.
There can be no purpose to this kind of recruitment other than to insinuate that adult smokers who choose to use e-cigarettes or smokeless tobacco are not reducing their risks. This would involve intentionally ignoring their own estimates that most people who die from smoking do so after they quit, often many years later; instead they appear poised to attribute the disease to their recent behavior rather than their long-term history of smoking.
We understand, of course, the problems from a regulatory standpoint of manufacturers making therapeutic or modified risk claims. However, there is a big difference between prohibiting manufacturers from informing their customers of potential health benefits associated with switching to e-cigarettes or smokeless tobacco versus the government actively misleading and misinforming the public about those risks. As consumer representatives, we believe this is a shocking breach of faith.
CDC has also misrepresented data regarding e-cigarette use by children. Clearly, the agenda is to report the data in a distorted manner so as to justify draconian regulation of e-cigarettes in order to "save the children." (CASAA supports bans on sales to minors, but opposes restrictions that serve primarily to reduce the availability, affordability, or quality of these potentially life-saving products for adult consumers.)
In an interview with the Los Angeles Times, Dr. Frieden stated, "The challenge that the FDA has is that they will be challenged by the tobacco industry, as they have been at every step of the way," and he then went on to say that FDA "tried to regulate e-cigarettes earlier, and they lost to the tobacco industry. . . . So the FDA has to balance moving quickly with moving in a way that's going to be able to survive the tobacco industry's highly paid legal challenge."
The lawsuit he alluded to was waged by two small (at the time) e-cigarette companies which were not at all affiliated with any of the traditional tobacco companies, contrary to Dr. Frieden’s explicit claim. In fact, the traditional tobacco companies are latecomers to the e-cigarette market, jumping in after the market had been developed by a consumer-driven e-cigarette industry. He claims that the tobacco industry is the threat to the recently proposed regulations, but it is generally acknowledged that the barriers to commerce created by the proposed regulations are so high that it is only the large tobacco companies that will be able to stay in the market. It is their competition from outside the traditional tobacco sector -- small businesses who make higher-quality products that consumers prefer -- that would be forced out of business by the burden of “red tape” requirements that create no apparent benefits. Thus, the opposition to the regulations is coming primarily from consumer and small businesses, not the traditional tobacco industry.
There are possibly regulations that would be genuinely beneficial to the American people. However, it does not appear that the proposed regulations would serve any such purpose (other than banning sales to children, which most states already do or will do soon). While the stated justifications for the regulations acknowledge a few of these genuinely beneficial actions (like protecting against contamination or poor manufacturing practices), the proposed regulations actually do nothing to address those issues.
We are further concerned about FDA's apparent lack of understanding of the relevant science. In addition to proposing regulations that would completely destroy the diversity in the marketplace -- eliminating the quality and variety that make e-cigarettes such an effective alternative for adult smokers -- the draft regulation documents are filled with misleading scientific claims that are either only vaguely supported by cherry-picked evidence or not supported at all. We have only just begun to document these, but expect to generate hundreds of pages of analysis about the false and misleading scientific claims in these regulation documents.
The content of the proposed regulations downplays all of the positive evidence about e-cigarettes (as we began to document), while blindly accepting negative claims. Perhaps most notably, CASAA provided a research grant (funded by donations from our membership) to a professor at Drexel University. He reviewed all the available evidence about the chemicals e-cigarette users and bystanders are exposed to, and he concluded (based on the extensive science that exists about such exposures) that the risks from all the measured chemicals are trivial. A preliminary version of this report has been available for almost a year and was very widely discussed (which is to say, FDA obviously knew about it and its importance for a very long time; we gave it to them ourselves) and it was published in a peer-reviewed academic journal well before FDA released their draft regulation. It is the single most important analysis on the topic, and yet it is not mentioned in the ostensibly scientific analysis in the draft regulation which includes nearly 200 other references.
CDC and FDA -- and Senator Harkin -- frame this as a battle between government (supposedly representing the interests of the public) versus so-called "Big Tobacco." The truth, however, is that the CDC and the FDA have demonstrated a shocking disregard of the interests of consumers, the single most important stakeholder in this entire process. The people who matter the most in all of this are those who use (or in the future may use) e-cigarettes as a low-risk alternative to smoking. The American people are being completely ignored. Moreover, as noted previously, imposing almost insurmountable burdens on "industry" has the effect of destroying the diverse marketplace that has allowed millions of people worldwide to eliminate or reduce their smoking habit, and then hand what remains of the sector to those very companies they denigrate as “Big Tobacco.”
Central to CASAA's mission is the importance of providing truthful and accurate information so that people can make informed choices, and also so that those entrusted with the responsibility of governance can make responsible legislative and regulatory policy. CASAA is the leading representative of the growing population of politicized American e-cigarette users; we estimate that as many as a few hundred thousand of them have become single-issue voters passionately interested in protecting their access to e-cigarettes. It is that important to them. We understand that testimony will be limited to CDC and FDA at this hearing. However, we respectfully request that should any future hearings occur, we be given an opportunity to present testimony on behalf of consumers.
On behalf of our membership, we respectfully request your help in making sure that the interests of consumers -- both current users of low-risk alternatives to smoking such as e-cigarettes, as well as those who may choose to use those products in the future -- are represented in this hearing.
Julie Woessner, President
The Consumer Advocates for Smoke-free Alternatives Association (CASAA)
 By way of background, CASAA is a non-profit 501(c)(4) NGO, providing public health science and public education. We are an all-volunteer organization with a grassroots membership of nearly 20,000 individuals from all walks of life. We are a consumer advocacy organization, not a trade association or industry representative. CASAA is dedicated to ensuring the availability of low-risk alternatives to smoking and to providing smokers and nonsmokers alike with honest information about those alternatives. Since CASAA's founding in 2009, we have educated the public and increased awareness about the benefits of low-risk alternatives to smoking, including e-cigarettes. We also advocate for responsible legislative policy designed to improve public health by recognizing that smoke-free nicotine-containing products are inherently far less hazardous than smoking.
 Examples of Dr. Frieden's aggressive dismissal of thousands of “anecdotes” can be found in the Los Angeles Times http://www.latimes.com/science/sciencenow/la-sci-sn-why-tom-frieden-hates-electronic-cigarettes-cdc-20140429-story.html and an interview with NPR http://www.npr.org/templates/transcript/transcript.php?storyId=306542127.
 A discussion of this issue by CASAA’s Scientific Director, Dr. Carl V. Phillips, can be found here: http://antithrlies.com/2013/09/07/cdc-lies-about-kids-using-e-cigarettes/. (See also an analysis by CASAA Director Elaine Keller of claims made by Dr. Frieden in an interview with Medscape last year, http://antithrlies.com/2013/10/08/cdc-director-misleads-medscape/.)
 See CASAA's preliminary analysis of the proposed FDA regulations: http://blog.casaa.org/2014/04/casaa-assessment-of-fda-deeming.html.
 E.g., http://antithrlies.com/2014/05/09/scientific-claims-in-the-fda-deeming-regulation-part-2-of/.